Back Pain, Leg Pain
Conditions
Brief summary
This study characterized the effects of amplitude on subject satisfaction and pain relief in subjects being treated by SCS.
Detailed description
This feasibility study assessed the following outcomes: * Patient satisfaction * VAS pain scores
Interventions
DEVICESpinal Cord Stimulation
Programming
Sponsors
MedtronicNeuro
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 22 years of age or older 2. Implanted with a RestoreSensor system (for back and leg pain) for at least 1 month 3. Has approproate SCS settings 4. Willing and able to provide signed and dated informed consent 5. Capable of comprehending and consenting in English 6. Capable of getting into the supine and sitting positions 7. Willing and able to comply with all study procedures and visits 8. On stable (no change in dose, route, or frequency) prescribed pain medications
Exclusion criteria
1. Implanted with leads for peripheral nerve stimulation or an implantable intrathecal drug delivery system 2. Had a pain-related surgery in the previous 1 month of enrollment or the intent to undergo surgery during the period of the study 3. Implanted with quadripolar lead 4. Currently enrolled or planning to enroll in a potentially confounding clinical study during the course of the study 5. Pregnant or is of child-bearing potential and unwilling to use a medically acceptable form of birth control during the study 6. Has untreated major psychiatric comorbidity 7. Has serious drug-related behavioral issues 8. Has unresolved major issues of secondary gain
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SCS Therapy Satisfaction | 8 weeks | To characterize the effect of four different amplitude settings on baseline SCS therapy satisfaction. At each follow-up visit, the following question was asked to measure satisfaction: Overall how satisfied or unsatisfied are you with this therapy?. The response choices were as follows: very satisfied, somewhat satisfied, neutral, somewhat unsatisfied, very unsatisfied. Each subject was considered to have maintained their baseline SCS therapy satisfaction if they selected the response very satisfied, somewhat satisfied, or neutral, otherwise they were considered dissatisfied with the therapy. The first visit in which each subject reported dissatisfaction of the therapy was recorded. The amplitude used during the prior visit was then considered to be the minimum amplitude that maintained each subject's therapy satisfaction. The frequency and percentage of subjects' that maintained baseline satisfaction were reported at each amplitude level. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Maintaining Baseline Pain as Measured on the Visual Analog Scale (VAS) | 8 weeks | To characterize the effect of four different amplitude settings on baseline pain relief. During each follow-up period the VAS pain score was recorded once a day, on a multi-day diary, where subjects rated their pain by making a vertical slash mark through the 0-10 cm line that best described their pain during the last 24 hours, with 0 = No pain and 10 = Worst pain imaginable. The higher VAS pain score represented worse pain. The average VAS pain scores from the last 3 days of the diary prior to the scheduled visit was used for analysis. Each subject was considered to have maintained their baseline pain if there was less than a 2 point increase in their average pain score at the follow-up period. The amplitude used during the prior visit was then considered to be the minimum amplitude that maintained the subject's pain relief. The frequency and percentage of subjects' that maintained their average baseline VAS pain score were reported at each amplitude level. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Spinal Cord Stimulation Each subject was programmed to 4 different amplitude settings (80, 60, 40, and 20 percent of their perception threshold).
Spinal Cord Stimulation: Programming | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | Spinal Cord Stimulation |
|---|---|
| Age, Continuous | 65.1 years STANDARD_DEVIATION 11.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 30 Participants |
| Region of Enrollment United States | 30 participants |
| Sex: Female, Male Female | 23 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 5 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
SCS Therapy Satisfaction
To characterize the effect of four different amplitude settings on baseline SCS therapy satisfaction. At each follow-up visit, the following question was asked to measure satisfaction: Overall how satisfied or unsatisfied are you with this therapy?. The response choices were as follows: very satisfied, somewhat satisfied, neutral, somewhat unsatisfied, very unsatisfied. Each subject was considered to have maintained their baseline SCS therapy satisfaction if they selected the response very satisfied, somewhat satisfied, or neutral, otherwise they were considered dissatisfied with the therapy. The first visit in which each subject reported dissatisfaction of the therapy was recorded. The amplitude used during the prior visit was then considered to be the minimum amplitude that maintained each subject's therapy satisfaction. The frequency and percentage of subjects' that maintained baseline satisfaction were reported at each amplitude level.
Time frame: 8 weeks
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Spinal Cord Stimulation | SCS Therapy Satisfaction | 60% perception threshold | 1 Participants |
| Spinal Cord Stimulation | SCS Therapy Satisfaction | 40% perception threshold | 0 Participants |
| Spinal Cord Stimulation | SCS Therapy Satisfaction | Baseline | 6 Participants |
| Spinal Cord Stimulation | SCS Therapy Satisfaction | 80% perception threshold | 2 Participants |
| Spinal Cord Stimulation | SCS Therapy Satisfaction | 20% perception threshold | 21 Participants |
Secondary
Number of Participants Maintaining Baseline Pain as Measured on the Visual Analog Scale (VAS)
To characterize the effect of four different amplitude settings on baseline pain relief. During each follow-up period the VAS pain score was recorded once a day, on a multi-day diary, where subjects rated their pain by making a vertical slash mark through the 0-10 cm line that best described their pain during the last 24 hours, with 0 = No pain and 10 = Worst pain imaginable. The higher VAS pain score represented worse pain. The average VAS pain scores from the last 3 days of the diary prior to the scheduled visit was used for analysis. Each subject was considered to have maintained their baseline pain if there was less than a 2 point increase in their average pain score at the follow-up period. The amplitude used during the prior visit was then considered to be the minimum amplitude that maintained the subject's pain relief. The frequency and percentage of subjects' that maintained their average baseline VAS pain score were reported at each amplitude level.
Time frame: 8 weeks
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Spinal Cord Stimulation | Number of Participants Maintaining Baseline Pain as Measured on the Visual Analog Scale (VAS) | Baseline | 5 Participants |
| Spinal Cord Stimulation | Number of Participants Maintaining Baseline Pain as Measured on the Visual Analog Scale (VAS) | 80% perception threshold | 3 Participants |
| Spinal Cord Stimulation | Number of Participants Maintaining Baseline Pain as Measured on the Visual Analog Scale (VAS) | 60% perception threshold | 1 Participants |
| Spinal Cord Stimulation | Number of Participants Maintaining Baseline Pain as Measured on the Visual Analog Scale (VAS) | 40% perception threshold | 2 Participants |
| Spinal Cord Stimulation | Number of Participants Maintaining Baseline Pain as Measured on the Visual Analog Scale (VAS) | 20% perception threshold | 19 Participants |